Abbreviated New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) | Indication | Launch Date |
| Balcoltra | Avion | levonorgestrel / ethinyl estradiol | Lupin | Used by females of reproductive potential to prevent pregnancy. | 1/13/2025 |
| Vitamin K1 | Hospira | phytonadione | Glenmark | Used to treat coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. | 1/21/2025 |
| Chlorpromazine | Hikma | chlorpromazine | Piramal | Used to manage and treat schizophrenia, bipolar disorder, and acute psychosis. | 1/22/2025 |
| Rapamune | Pfizer | sirolimus | Camber | Used for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. | 1/29/2025 |
| Miacalcin | Mylan | calcitonin salmon | Fresenius Kabi | Used to treat postmenopausal osteoporosis when alternative treatments are not suitable. | 2/10/2025 |
| Evoclin | Mylan | clindamycin | Glenmark | Used to treat serious infections caused by susceptible anaerobic, streptococcal, staphylococcal, and pneumococcal bacteria. | 2/12/2025 |
| Asacol HD | AbbVie | mesalamine | Amneal | Used to treat moderately active ulcerative colitis in adults. | 2/19/2025 |
| Epinephrine | BPI Labs | epinephrine | Glenmark | Used to treat hypotension associated with septic shock and for emergency responses to allergic reactions. | 2/28/2025 |
| Acetadote | Cumberland | acetylcysteine | Glenmark | Used to treat acetaminophen (Tylenol) overdose to prevent liver damage. | 3/3/2025 |
| MiraLax | Bayer HealthCare | polyethylene glycol 350 | Glenmark | Used to treat constipation in patients 17 years of age and older. | 3/10/2025 |
| Sandostatin LAR | Novartis | octreotide | Teva | Used to treat acromegaly, diarrhea and flushing associated with carcinoid tumors, and profuse watery diarrhea from VIPomas, as well as other conditions like esophageal variceal bleeding and GI fistulas. | 3/20/2025 |
| Gleevec | Novartis | imatinib | Apotex | Used to treat different types of cancer or bone marrow conditions. | 3/27/2025 |
